Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis

Sponsor
Tom Appleton
Study ID
NCT06037811
Phase
PHASE2
Status
Recruiting
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Conditions

  • Immune-related Adverse Event
  • Inflammatory Arthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Participants will be randomized 1:1 (non-blinded) to receive either adalimumab (40 mg subcutaneous every 2 weeks for 12 weeks) and prednisone vs prednisone alone. Addition of methotrexate (MTX) and/or hydroxychloroquine (HCQ) is permitted, as needed, at the discretion of the treating rheumatologist. No additional conventional synthetic, targeted synthetic or biologic DMARDs are permitted during the trial.
  • Prednisone — DRUG
    Prednisone as per standard of care. The 12-week glucocorticoid regimen and taper will be standardized between the groups. At Baseline, all participants will be switched to oral prednisone dose at 10, 20, 30, 40, 50, or 60 mg once daily. The initial dose of prednisone is at the discretion of the investigator, based on disease severity and comorbid medical conditions, at a minimum of 10 mg once daily at Baseline. At Baseline, if a participant is on a dose other than 10, 20, 30, 40, 50, or 60 mg QD, the dose will be rounded up or down, as clinically indicated per investigator discretion, to the nearest of these doses. The prednisone taper regimen is tailored to each patient based on the starting dose over a 12-week period.

Study Details

This study will examine the effectiveness of administering adalimumab as a treatment for patients in the early stages of steroid-dependent immune checkpoint Inhibitor associated inflammatory arthritis (ir-IA). Adalimumab (ADA) is a TNF inhibitor (TNFi) that is well established as a standard of care treatment for numerous types of inflammatory arthritis. It is hoped that adalimumab at the early stages of the ir-IA will reduce the symptoms and therefore reduce the need for steroids. This study is a pragmatic randomized clinical trial. Patients will be randomized 1:1 to each treatment group. To evaluate the steroid sparing effect of early induction six doses of Adalimumab will be administered to patients in the study treatment arm as compared to the usual standard of care of a predefined corticosteroid regimen and taper at 12 weeks administered in the control group.

Key Dates

Start date
Apr 15, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of care group
    Baseline oral prednisone dose taken daily for one week, then weekly prednisone taper for 12 weeks or until stopped according to the 12-week Glucocorticoid Tapering Schedule
  • Active Comparator: Adalimumab group
    Adalimumab 40mg SC every 2 weeks x 6 doses + Baseline oral prednisone dose taken daily for one week, then weekly prednisone taper for 12 weeks or until stopped according to the 12-week Glucocorticoid Tapering Schedule.

Primary Outcome Measure

percentage of participants on prednisone [ Time Frame: at 12 weeks ]

Central Contacts

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